AttraX® Putty vs. Autograft in XLIF® (NCT02250248) | Clinical Trial Compass
CompletedNot Applicable
AttraX® Putty vs. Autograft in XLIF®
Brazil45 participantsStarted 2014-12
Plain-language summary
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Persistent back and/or leg pain unresponsive to conservative treatment for at least 6 months, unless surgical treatment is clinically indicated sooner
. Indicated for a single-level XLIF between L1 and L5 with bilateral percutaneous pedicle screws
. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
. 18-80 years of age at the date of written informed consent
. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
. Expected to survive at least 2 years beyond surgery
. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
. Signed and dated informed consent form
Exclusion criteria
. Mental or physical condition that would limit the ability to comply with study requirements
. Spine abnormality requiring treatment at more than one level
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number and percentage of subjects with radiographically apparent fusion 24 months.